Persistent Allergic Rhinitis MedDRA version: 9.1 Level: LLT Classification code 10034382 Term: Perennial allergic rhinitis MedDRA version: 9.1 Level: LLT Classification code 10039776 Term: Seasonal allergic rhinitis
Conditions
Interventions
Product Name: Rupatadine
Pharmaceutical Form: Oral solution
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Sponsors
J. Uriach y Compañía, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Boys and girls between 6 and 11 years old, inclusive, at screening. (2) Weight above than 16 Kg. (3) Documented history of persistent allergic rhinitis of at least 12 months before the selection visit. (4) Skin Prick test positive of 3 mm greater than the negative control to at least one of the following: housedust mites (Der p 1 and der f 1), fungal spores (alternaria, aspergillus, cladosporium), and Grass pollens (bermuda and Rye); and symptomatic for more than 4 weeks to the allergen to which they are positive (ARIA guideline). (5) Results of standard laboratory tests within acceptable limits as assessed by investigator. (6) Girls of child bearing potential should have a negative pregnancy test at the time of inclusion. In addition, if sexually active, they must use contraceptive measures (e.g oral contraceptives or double-barrier contraception). The commitment of the patient to use these measures while participating in this clinical trial will be considered as sufficient. (7) A 12 lead ECG obtained at screening within acceptable limits, moreover in absence of any drug effect or disease, QTc interval values (msec) after Bazzet’s correction must be normal (not prolonged). The values considered to be normal are ? 430 msec for boys and ? 450 msec for girls. (8) Children who have written consent from their parent/guardian to participate in the study. Children who are considered mature enough to understand an assent form will be invited to give written assent. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (1) Clinically relevant abnormal physical findings which could interfere with the objectives of the study. (2) Clinically relevant abnormal laboratory values indicative of physical illness. (3) Ascertained of presumptive hypersensitivity to the active principle and/or formulation ingredients of the tested compounds such as children with lactose intolerance. (4) Children under any systemic or topical medication for AR and/or an inferior wash-out period as stated as follows: corticosteroids (depot, 90 days; systemic 30 days; dermatologic 14 days), cromones (14 days), antihistamines (astemizole, 90 days; ketotifen, 10 days; nasal and long-acting oral, 10 days; short-acting oral, 12-48 hours; ocular, 3 days), decongestants (1-3 days), leukotriene inhibitors (10 days), herbal remedies (3 days), systemic antibiotics (14 days), anticholinergic (7 days), any potential inhibitor of CYP3A4 such as ketoconazole, erythromycin and/or tricyclic antidepressants, e.g. imipramin, amitriptilin, (28 days), ophthalmic non-steroidal anti-inflammatory drugs (3 days), nasal-ophthalmic wash solutions (12 h) and immunotherapy. Regular schedule immunotherapy can be maintained throughout the study but will be disallowed from 24h prior to first study dosing. Child with mild asthma treated with inhaled bronchodilators or inhaled corticosteroids of = 800 mcg/day of budesonide or beclomethasone, or with = 500 mcg/day of fluticasone will be allowed in the study upon specific sponsor approval. (5) Children taking medication that is known to interact significantly with CYP3A4 isozyme of cytochrome P450 such as amiodarone, carbamazapine, cyclosporin, terfenadine, glucocorticoids, phenytoin, rifampicin, erythromycin, ketoconazole as well as grapefruit juice. (6) Children that after review of their medical history, is considered by the investigator as unresponsive to antihistaminic treatment. (7) Children whose health could be harmed by their participation in the study at investigator criteria. (8) Girl who is pregnant or lactating. (9) History of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may impact on the outcome of the study. (10) Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, haematological, endocrine or neurological diseases that may interfere with the aim of the study. (11) History of chronic nasal or upper respiratory symptoms/disorders, nasal polyps and significant deviation of nasal septum. (12) History of non-allergic rhinitis (vasomotor, infectious, drug-induced, etc). (13) Chronic sinusitis or severe bronchial asthma. (14) Respiratory infection in the last 30 days before the study start. (15) Children unable to comply with the study requirements (attendance to visits), unable to complete the patient diary and take the study treatment, or children that should have to travel to another geographic area during the course of the study. (16) Children who have a recent history (within previous 12 months) of drug addiction or alcohol abuse. (17) Children taking drugs strongly associated with torsade de pointes such as disopyramide, procainamide, quinidine, amiodarone, sotalol, thioridazine, beperidil or prenylamine. (18) Participation in the evaluation of any drug within 3 months prior to the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study objective is to assess the efficacy and safety of rupatadine solution over a period of 28 to 42 days in children between 6 and 11 years old with persistent allergic rhinitis. The main efficacy endpoint will be the change in the total score of the patient symptoms (T4SS) over the 28 days of treatment with rupatadine solution (patient diary card reflective 24 hours symptoms, all days including the same visit days with the investigator).;Primary end point(s): Change from baseline in the Total 4 Symptoms Score of the patient (T4SS) over 28 days of treatment (reflective 24 hours symptoms assessment).;Secondary Objective: Change from baseline in the total score after 42 days of treatment. Change in the total score during the 28 and 42 days of treatment. Change in the daily score for each symptom from baseline during 28 and 42 days. Mean value of the daily total score of symptoms Time to beginning of action (first week). Maximum value of the daily score of each symptom Maximum value of the total daily symptom score Percentage of days during the study period when the maximum daily score was from 0 to 1 Percentage of days during the study period when the maximum daily score was 0 Percentage of patients requiring rescue medication. Assessment of instantaneous symptoms severity (both patient and investigator) Assessment of instantaneous effectiveness (both patient and investigator) Paediatric Rhinoconjuntivitis Quality of Life (PRQLQ) Safety measurements will include: Adverse Events incidence Related Adverse Events incidence Serious Adverse Events incidence | — |
Countries
Hungary, Spain
Outcome results
None listed